Rheumatology, Reade, Amsterdam Rheumatology and Immunology Center, Amsterdam, North Holland, The Netherlands
Epidemiology and Data Science, Amsterdam Public Health, Amsterdam UMC Location VUmc, Amsterdam, The Netherlands.
RMD Open. 2021 Mar;7(1). doi: 10.1136/rmdopen-2021-001592.
Several trials to test the efficacy of a pharmacological intervention aimed at primary prevention of rheumatoid arthritis (RA) are ongoing or have recently been completed. A common issue in these trials is the severe difficulty with patient recruitment. In order to enhance recruitment, this qualitative study identified barriers and facilitators of individuals at risk of RA to participate in a prevention trial.
Individuals at risk of developing RA (ie, arthralgia with anticitrullinated protein antibodies and/or rheumatoid factor without arthritis), who had previously been asked to participate in a prevention trial, participated in focus group discussions (n=18) exploring their facilitators and barriers for trial participation. Thematic analysis identified factors that were important in at-risk individuals' decision about trial participation.
The prospect of personal benefit, the acknowledgement of one's symptoms and the desire to contribute to society facilitated trial participation. In contrast, misconception about what it means to be at risk, or about the aim of the prevention trial, negative views on trial medication, and a low perceived urgency to act on the possibility of developing RA versus a high perceived burden of participating in a trial discouraged participation.
To enhance inclusion in trials aimed to prevent RA, the results suggest to use strategies such as optimising education about RA, personal risk, trial aim and trial medication, explicitly addressing misconceptions and concerns, using tools to improve information provision, limiting study burden in trial design and encouraging physicians to mention trial participation.
目前有几项旨在对类风湿关节炎（RA）进行一级预防的药物干预试验正在进行或最近已经完成。这些试验的一个共同问题是患者招募非常困难。为了提高招募效率，这项定性研究确定了处于 RA 风险中的个体参与预防试验的障碍和促进因素。
有发展 RA 风险的个体（即抗瓜氨酸化蛋白抗体和/或类风湿因子阳性但无关节炎的关节痛），之前被邀请参加预防试验，他们参加了焦点小组讨论（n=18），探讨了他们参与试验的促进因素和障碍。主题分析确定了对处于风险中的个体参与试验决策很重要的因素。
个人获益的前景、对自身症状的认识以及为社会做出贡献的愿望促进了试验参与。相比之下，对处于风险中的意义或预防试验的目的、对试验药物的负面看法、以及对发展 RA 的可能性采取行动的感知紧迫性与参与试验的感知负担之间的权衡，阻碍了参与。
为了增加旨在预防 RA 的试验的纳入，研究结果表明，可以采用以下策略，例如优化有关 RA、个人风险、试验目的和试验药物的教育，明确解决误解和顾虑，使用工具来改善信息提供，在试验设计中限制研究负担，并鼓励医生提及试验参与。
